Rockville, MD, USA (PRWEB) January 30, 2014
The Regulatory Affairs Professionals Society (RAPS) has updated its essential reference text, Fundamentals of Canadian Regulatory Affairs, the only book of its kind extensively covering the regulation of healthcare products marketed in Canada. The book is part of RAPS’ popular Fundamentals series, which also includes books on regulations in the US, EU and Japan, as well as a book on global standards.
Fundamentals of Canadian Regulatory Affairs, Fourth Edition reflects the changes in technology in the three years since the previous edition was published in 2011, and examines their impact on regulations. New chapters have been added on regulation of products for small patient populations, health technology assessment and reimbursement, development of products for pediatric populations and pharmacovigilance.
“This book’s four sections covering general information, drugs and biologics, medical devices and other product categories comprise just about everything relating to healthcare product regulation by Canadian authorities,” said RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE. “It is one reference everyone working with Canada’s regulations should definitely have.”
In addition to being a useful reference, many professionals preparing for the Canadian Regulatory Affairs Certification (RAC) exam cite Fundamentals as an important study tool.
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Europe and Asia, and chapters and affiliates worldwide. RAPS.org